MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

In 2011, a general surgeon operated on a patient for laparoscopic cholecystectomy procedure using an er320 product (no expiration date & lot number is available).After an unknown period of time, after a diagnostic test, a "floating" clip was found low on the patient's pelvis, which resulted in another surgeon convincing the patient that re-operation was needed in order to remove it, otherwise (according to the second surgeon) the patient was at risk of suffering gynecological complications.As a result, the patient was re-operated on by the second surgeon.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9335487
• MDR Text Key: 185062032
• Report Number: 3005075853-2019-23547
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1